Ankle-Foot Orthosis and Method of Manufacture

ABSTRACT

An ankle-foot orthosis for a lower leg, ankle, and foot of a patient, the ankle-foot orthosis including: a foot plate; a calf-cuff member; and a strut member extending between the foot plate and the calf-cuff member, the strut member coupling to an arch region of a medial side of the foot plate and a posterior side of the calf-cuff member, the strut member being formed from layers of carbon fiber and at least one layer of a thermoplastic material.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part (“CIP”) applicationof, and claims priority to, U.S. patent application Ser. No. 14/859,025,which was filed Sep. 18, 2015, entitled “ANKLE-FOOT ORTHOSIS AND METHODOF MANUFACTURE,” and is hereby incorporated by reference in its entiretyinto the present application.

U.S. patent application Ser. No. 14/859,025 claims priority under 35U.S.C. §119 to U.S. Provisional Patent Application No. 62/052,615, whichwas filed Sep. 19, 2014, entitled “ANKLE-FOOT ORTHOSIS AND METHOD OFMANUFACTURE,” and is hereby incorporated by reference in its entiretyinto the present application.

TECHNICAL FIELD

Aspects of the present disclosure involve orthoses, and moreparticularly, involve ankle-foot orthoses.

BACKGROUND

A variety of medical conditions may cause a patient to use an orthosis,which is a device that is externally applied to a patient's body to aidor supplement the patient's neuromuscular and skeletal system. Patientswith hypotonia, for example, may have low muscle tone in certain legmuscles and may require the aid of an orthosis to provide support tolesser toned muscles. The orthosis helps the patient walk withoutcollapsing forward or hyperextending backwards due to the inability ofthe lesser toned muscles to support the patient's body. As anotherexample, patients with hypertonia may have high muscle tone in certainleg muscles (e.g., calf muscle) and may require the aid in an orthosisto position the foot in a relaxed or more natural position, and to helpthe make sure the foot does not hang and drag as the patient walks. Withthese types of conditions, among others, an ankle-foot orthosis(hereinafter “AFO”) may be beneficial to help correct the imbalance ofmuscles in the patient's legs.

An AFO is a type of orthosis that supports both the foot and the ankleby controlling the position and motion of the ankle. As mentioned above,an AFO can be used by for both weak, lesser toned limbs and contractedlimbs. In addition, an AFO can be used for immobilization purposes(e.g., broken bone). Conventional AFO's form an “L” shape with an uppersupport that contacts a posterior side of a patient's lower leg with astrap securing around the patient's calf and a lower support thatcontacts an inferior side of the patient's foot. In conventional AFO's,there may or may not be a hinge mechanism at the ankle and there may ormay not be additional straps throughout the “L” shape to secure thebrace to the patient's leg.

Certain AFO designs may also include a Supra-Malleolar orthosis(hereinafter “SMO”) that fits within the AFO to provide additionalforefoot, mid-foot, and subtalar stability. Conventional SMO's wraparound a patient's foot and ankle to compress the soft tissue of thefoot. The compression of the SMO helps to stabilize the foot and ankle,which helps the patient develop a more natural gait when walking.

While beneficial and useful to patients, some conventional AFO designsstill suffer from many drawbacks.

SUMMARY

Aspects of the present disclosure may involve an ankle-foot orthosis fora lower leg including a calf, ankle, and foot of a patient. Theankle-foot orthosis may include a foot plate, a calf-cuff member, and asupport member. The foot plate may include a toe side, a heal sideopposite the toe side, a medial side including an arch region, and alateral side opposite the medial side. The calf-cuff member may beconfigured to abut the calf of the patient. The support member mayextend between the foot plate and the calf-cuff member, the supportmember consisting of a strut member including a curved lower section anda straight upper section, the curved lower section extending from thearch region of the medial side of the foot plate to a posterior positionabove the heal side of the foot plate, the curved lower sectiontransitioning to the straight upper section at the posterior position,the straight upper section extending superiorly to the calf-cuff member.

In certain instances, the heal side defines a gap between the strutmember and the foot plate.

In certain instances, the heal side of the foot plate may be unconnectedto the strut member.

In certain instances, the strut member may be widest at the arch region.

In certain instances, the foot plate may be custom contoured to the footof the patient.

In certain instances, the calf-cuff may be custom contoured to the calfof the patient. In certain instances, at least one of the foot plate orthe calf-cuff member may be custom contoured to the calf of the patient,and an inner surface of the strut member may be not custom contoured tothe patient.

In certain instances, a heal portion of an inner brace positioned withinthe ankle-foot orthosis extends further posteriorly than any portion ofthe ankle-foot orthosis.

In certain instances, the strut member may be constructed of carbonfiber.

In certain instances, the strut member may be constructed of layers ofbi-directional and uni-directional carbon fiber.

Aspects of the present disclosure may involve a method of manufacturinga custom ankle-foot orthosis for a patient's lower leg and foot, themethod may include: forming an inner brace from molding a first materialover a first portion of a positive mold of the patient's lower leg andfoot; modifying the positive mold to form a modified positive mold; andforming an outer brace by molding at least one second material over asecond portion of the modified positive mold.

In certain instances, the first material may be a thermoplasticmaterial.

In certain instances, the at least one second material may includecarbon fiber.

In certain instances, the at least one second material further mayinclude a thermoplastic material.

In certain instances, the positive mold may include a cast of thepatient's lower leg and foot.

In certain instances, modifying the positive mold to form the modifiedpositive mold may include removing custom contouring aspects of thepositive mold.

In certain instances, modifying the positive mold to form the modifiedpositive mold may include forming a flattened portion of the positivemold.

In certain instances, the flattened portion of the positive mold mayinclude a band extending from a posterior region to a medial archregion.

In certain instances, the outer brace may include a foot plate, acalf-cuff member, and a strut member coupled between the foot plate andthe calf-cuff member, the flattened portion of the positive mold mayinclude an area to which the strut member may be molded.

In certain instances, the outer brace may include only one strut memberincluding the strut member.

BRIEF DESCRIPTION OF THE DRAWINGS

Example embodiments are illustrated in referenced figures of thedrawings. It is intended that the embodiments and figures disclosedherein are to be considered illustrative rather than limiting.

FIG. 1A is a side view of a first embodiment of an outer brace of anAFO;

FIG. 1B is a back view of the first embodiment of the outer brace ofFIG. 1A;

FIG. 10 is a close-up front view of the first embodiment of the outerbrace of FIG. 1A;

FIGS. 2A is a perspective view of a second embodiment of an outer braceof an AFO;

FIG. 2B is a perspective view of the outer brace of FIG. 2A flexing in asimulated plantarflexion position of a patient's leg;

FIG. 2C is a back view of the outer brace of FIG. 2A;

FIG. 2D is a close-up side view of overlapping struts in the outer braceof FIG. 2A;

FIG. 2E is a side view of the outer brace of FIG. 2A;

FIG. 3 is a perspective view of an inner brace of the AFO;

FIG. 4 is a flowchart of the manufacturing process for an embodiment ofthe AFO;

FIG. 5 is a flowchart of the manufacturing process for anotherembodiment of the AFO;

FIG. 6 is a perspective view of an empty cast;

FIG. 7 is a perspective view of a positive mold formed from the emptycast;

FIG. 8 is a close-up perspective view of a modification of the plastermold;

FIG. 9 is a rear isometric view of an inner brace shell;

FIG. 10 is a rear isometric view of a dummy mold showing a flattenedarea on a posterior side of the mold;

FIGS. 11-13 are views of the dummy mold with a first layer of carbonfiber being wrapped around the dummy mold;

FIG. 14 is a view of the dummy mold with a thin layer of thermoplasticpositioned over the location of the strut member (not shown);

FIGS. 15-17 are views of the outer brace before trimming excessthermoplastic from around the strut member;

FIG. 18 is a close-up view of the back of the calf-cuff member of thesecond embodiment of the outer brace;

FIG. 19 is a close-up view of the lower support member of the secondembodiment of the outer brace;

FIG. 20 is a front perspective view of a third embodiment of an outerbrace of an AFO;

FIG. 21 is a back perspective view of the third embodiment of the outerbrace of FIG. 20;

FIG. 22 is a front perspective view of a fourth embodiment of an outerbrace of an AFO;

FIG. 23 is a back perspective view of the fourth embodiment of the outerbrace of FIG. 23;

FIG. 24 is a back view of the fourth embodiment of the outer brace ofFIG. 22;

FIG. 25 is a lateral side view of the fourth embodiment of the outerbrace of FIG. 22; and

FIG. 26 is a medial side view of the fourth embodiment of the outerbrace of FIG. 22.

DETAILED DESCRIPTION

Aspects of the present disclosure involve an AFO that combines energyreturning and flexible characteristics of carbon fiber with enhancedflexibility traits of thermoplastics, among other features, to providean AFO that helps a patient develop a more natural gait across a rangeof motion from walking to running. More particularly, in one example, anAFO with a strut formed of the combined materials provides for a morerobust AFO that can withstand bending stresses placed on the AFO andparticularly the strut by active patients. Aspects of the presentdisclosure also involve an AFO that includes a multi-strut configurationthat provides sufficient flexibility and energy return, while at thesame time providing enhanced robustness that can withstand activebending, whether intentionally or unintentionally from patients.

In the various possible implementations discussed herein, the AFOincludes an outer brace and an inner brace. The inner brace is aform-fitted brace that is customized to match the contours of apatient's foot and ankle. The inner brace is semi-rigid and formed froma thermoplastic or similar material. The inner brace securely attachesto the patient's foot/ankle and fits within the outer brace. The outerbrace includes a foot plate, a calf-cuff, and either a single strutmember or a pair of strut members that couples the foot plate to thecalf-cuff. The foot plate and the calf-cuff of the outer brace mayinclude a custom-fit contour of the patient's specific anatomy, whilethe strut members may be formed to provide a consistent and predictableflexion point that is near or below the ankle regardless of thepatient's specific anatomy. The outer brace may be formed from layer ofcarbon fiber, fiberglass, and/or thermoplastic to provide the necessaryresistance to support the patient's leg in a natural position. Overall,the foot plate and the calf-cuff secure the AFO to the patient's footand lower leg, while the strut is the active component that flexes andprovides support to the patient's ankle and foot as they stand, walk,run, and otherwise go about their daily routine.

Referring to FIGS. 1A-1C, an outer brace 100 is shown in a side view,rear view, and front view, respectively. The outer brace 100 includes alower support member 102 that partially wraps around the foot and ankleof a patient's leg. In particular, the lower support member 102 wrapsaround portions of the ankle area and the plantar surface of the foot orinner brace while leaving the dorsal area of the foot or inner braceopen. The lower support member 102 includes a foot plate 104 thatcontacts an inferior surface of the inner brace (shown in FIG. 3) andruns from a heal-end of the outer brace to a toe-end of the outer brace.As seen in FIG. 1, the foot plate 104 may include open areas to reduceweight or to provide movement for the inner brace, which is not shown inFIG. 1. In particular, the foot plate 104 may include an open area 106in the area of the calcaneus, or heal bone, and may also include aninferior open area 108 in the mid-foot region. The foot plate couples toor transitions to a pair of sidewall members 110 on either side of theouter brace 100. Each of the sidewall members 110 includes a mid-footraised edge 112 that wraps around a mid-portion of the patient'sfoot/inner brace. Moving distally from the mid-foot raised edge 112 atthe mid-portion of the outer brace 100, the mid-foot raised edges 112taper down to the foot plate 104 at the toe-end of the outer brace 100.Moving proximally from the mid-foot raised edge 112, each of themid-foot raised edges 112 dips towards the foot plate 104 and thentransitions upward again to a hind-foot raised edge 114. Again, movingproximally from the hind-foot raised edges 114, each of the hind-footraised edges 114 dips towards the foot plate 104 and then couples with astrut member 116 at a proximal-most end of the heal-end portion of theouter brace 100.

The strut member 116 extends from the lower support member 102 on aposterior side of the foot above the calcaneus to a calf-cuff member118. The strut member 116 is a flexible/resilient semi-rigid memberformed from layers of carbon fiber 120 and one or more layers ofthermoplastic 122 or similar material. The strut member 116 extends on aposterior side of a patients calf and provides resistance and supportbetween the lower support member 102 and the calf-cuff member 118. Whilethe lower support member 102 and the calf-cuff member 118 are contouredto the patient's particular anatomy, the strut member 116 issubstantially flat or straight in a medial-lateral direction, in oneimplementation. Such a flat cross-section allows for maximum strengthwhen a patient's foot is in dorsiflexion as well as plantarflexion.Aspects of this disclosure involve a strut member formed of acombination of carbon fiber 120 and thermoplastic 122. Aspects of thedisclosure also contemplate a substantially flat strut member 116, ascompared to a contoured strut matching the ankle above a patients heal.Aspects of the present disclosure also contemplate a strut member 116with combined materials as well as a substantially flat portion abovethe heal

It has been found that while functional and reliable, introducingvariables associated with the strut member 116 could affect the flexionpoint of the AFO. For example, a strut member 116 that is contoured tothe patient's leg may introduce areas of stress concentrations, such asabrupt directional changes along the extension of the strut member 116between the lower support member 104 and the calf-cuff member 118. Insome instances, it may be preferable to include a contoured strut whereenhanced rigidity is sought without adding additional carbon layers. Thestress concentrations, however, may cause the strut member 116 to bendat the stress concentrations as opposed to bending at the point ofconnection with the lower support member. Also, the stressconcentrations may be subject to increase and/or abnormal wear, whichmay lead to failure of the AFO. Accordingly, in one possibleimplementation, the strut member 116 is flattened between the lowersupport member 104 and the calf-cuff member 118 such that the strutmember 116 may have more consistent mechanical properties that are notdependent on the specific contouring of the posterior surface of thepatient's leg.

Referring to the calf-cuff member 118, it may be manufactured fromcarbon fiber 120 and may wrap partially or wholly around the calf of thepatient. As with the lower support member 104, the calf-cuff member 118may be contoured specifically to the patient's calf. The calf-cuffmember 118 may additionally include a strap (not shown), such as aVelcro strap, that wraps around the front of the patient's leg andsecures the patient's leg to the calf-cuff member 118. With respect tothe calf-cuff member 118 and the lower support member 104, whiledescribed as being formed of carbon fiber 120, which allows the AFO tobe a unified piece, it is possible to fabricate the calf-cuff and lowersupport member form other materials and couple the strut member 116therebetween.

In use, the AFO functions as follows. A patient positions their footwithin an inner brace and secures the foot accordingly. The patient thensecures an outer brace 100 to the foot with the inner brace alreadysecured. In this step, the patient may secure the calf-cuff member 118to the calf area by sinching a strap around the calf, or otherwise. Asseen in FIG. 1A, the outer brace 100 is positioned in a neutral position(i.e., with a patient's foot in neither dorsiflexion nor plantarflexion)or in slight dorsiflexion or plantarflexion as needed for the specificpatient. As such, once the outer brace 100 is secured to the patient'sleg and the patient begins walking, the outer brace will flex about thestrut member 116 at the point of attachment to the lower support member104, and for a distance above the point of attachment. Thus, the strutmember 116 will flex to some degree along its length depending on theactivity of the patient. For example, as the patient steps forward withone leg while putting weight on the leg with the AFO, the AFO will flexin dorsiflexion to allow adequate step length and provide resistance tothe patient's leg from collapsing forward. As the stance leg moves intoterminal stance position it uses energy stored from dorsiflexed positionand releases energy to assist with active plantarflexion duringpush-off. This motion allows more normal and efficient walking patternand also allows for active muscle use by the patient and, therefore,strengthening of those muscles. And, as the patient steps forward withthe leg with the AFO, the AFO will flex in plantarflexion as the healarea contacts the floor and transfers weight onto the leg with the AFO(loading response). The strut will flex to a greater extent if thepatient is running or jumping as opposed to walking, for example.

Reference is now made to FIGS. 2A-D, which are views of a secondembodiment of an outer brace 200 of an AFO that employs multiple strutsor strut members 202 (in this example, two struts). Referring to FIG.2A, the outer brace 200 includes a lower support member 204 that issomewhat similar to the first embodiment illustrated in FIG. 1, but withmodifications to the heal-end portion 206 of the lower support member204 in order to change the stress concentrations and support the twostruts 202 with a unified lower support and strut. As with the firstembodiment, the second embodiment of the lower support member 204partially wraps around the ankle area and the plantar area of the footor inner brace while leaving the dorsal area of the foot or inner braceopen. The lower support member 204 includes a foot plate 208 thatcontacts the inferior surface of the inner brace and runs from theheal-end 206 of the outer brace to a toe-end 210 of the outer brace 200.The foot plate 208 couples to or transitions to a pair of sidewallmembers 212 on either side of the outer brace. Each of the sidewallmembers 212 includes a fin-shaped edge 214 that wrap around amid-portion of the patient's foot/inner brace. Moving distally from thefin-shaped edge at the mid-portion of the outer brace 200, thefin-shaped edges 224 taper down to the foot plate 208 at the toe-end 210of the outer brace 200. Moving proximally from the fin-shaped edge 214at the mid-portion of the outer brace 200, each of the fin-shaped edges214 dips towards the foot plate 208 and then transitions upward at anapproximate 45 degree angle where it forms an anterior side edge 216 ofa strut member 202 that extends towards the calf of the patient. Aposterior side edge 218, opposite the anterior side edge 216, of thestrut member 202 tapers down to the foot plate 208 while leaving open aposterior end of the heal-end 206 of the outer brace 200. Stateddifferently, the foot plate 208 terminates at the heal-end 206 of theouter brace 200 and the sidewall members 212 do not wrap around theposterior end of the heal-end 206. The opening 220 formed by the pair ofstruts 202 is a large opening in the area of the calcaneus and allowsfor movement of the inner brace relative to the outer brace 200.Additionally, the opening 220 formed by the pair of struts 202 allowseach strut to function independently so that the flex point comes from apoint below the ankle axis. If the struts 202 were coupled togetherabove the ankle, then the flex point would likely be above the ankle.The opening 220 formed by the pair of struts 202 allows for anadditional range of motion since the flex point is below the ankle.

As mentioned above, the sidewall members 212 of the lower support member204 couple to or transition to a pair of strut members 202, which extendupward towards the patient's calf. In the second embodiment of the outerbrace 200 and still referring to FIGS. 2C-2D, each strut member 202wraps around from the sidewall members 212 to a point 222 above thecenter heal-end 206 of the lower support member 204. At the centeredconvergence point 222, the struts 202 overlap for the extension from thecenter point 222 to the calf-cuff member 224. The struts 202 couple withthe calf-cuff member 224 on a posterior side of the patient's calf. Thecalf-cuff member 224 is similar to as described in FIG. 1.

Regarding the flexion of the outer brace 200, each of the strut members202 twists or rotates between 45 and 90 degrees from the point where thestruts 202 extend from the sidewall members 212 and the center point 222above the heal-end 206. Stated differently, the struts 202 form asubstantially flat cross-section and initially extend upward from theouter brace 200 on opposites sides of the heal. The struts 202 thentwist such that the flat area of each strut is parallel, overlapping,and roughly parallel to the tangent of the contour of the rear of thepatient's leg at the point 222 where the struts 202 converge. As seen inFIG. 2B, when the outer brace 200 is in plantarflexion, the rotation ofthe strut members 202 provides a mechanism to facilitate flexion of theAFO. In particular, as the outer brace 200 is flexed in plantarflexion,the strut members 202 flex in a general region between the center point222 and the sidewall members 212. Utilizing two strut members 202 insuch a manner can increase the rigidity of the outer brace 200 and,thus, allow for less material in the heal area of the brace 200, as seenin FIG. 2C, which is a back view of the outer brace 200 of the secondembodiment. Arranging the strut members 202 in this manner also allowsthe struts to independently flex according to the particular movementsof the patient. The struts 202 may, for example, independently flexoutward a small amount when the patient moves in dorsiflexion, whichincreases the strength of the struts 202 by reducing areas of stressconcentrations.

Referring now to FIG. 3, which is a perspective view of an inner brace300 of the AFO, the inner brace 300 includes a plantar support member302 that supports the inferior side of the patient's foot and sidesupporting members 304 that wrap around medial and lateral sides of thefoot. Each of the side supporting members 304 includes a lip 306 at atop edge of the side supporting surface 304 to decrease painful rubbingof inner brace 300 with the upper ankle of the patient. Additionally,the inner brace 300 includes a recessed posterior portion 308 of thebrace 300 where the two side supporting surfaces 304 meet posteriorly ofthe patient's calcaneus. The recessed posterior portion 308 allows forcomfortable movement of the patient, in particular, duringplantarflexion.

The inner brace 300 is form-fitted to a patient's foot and is securelyattached to the patient's foot such that when the patient walks (i.e.,with the inner brace positioned within the outer brace), the inner brace300 moves with the patient's foot with little or no flex, while theouter brace 100, 200 may flex or move relative to the inner brace 300.The inner brace 300 may include a strap (not shown) and/or cushioningmaterial on all or a portion of an inner surface of the inner brace. Inparticular, the cushioning material 310 may be positioned over boneyportions of the foot or ankle to provide comfort to the patient whenwalking with the AFO.

As far as the construction of the AFO, the outer brace 200 may bemanufactured entirely or partially from carbon fiber, which providesexcellent flexibility and strength to weight ratios. In particular, theouter brace 200 may be manufactured from sheets or rolls ofpre-impregnated carbon fiber (i.e., resin or epoxy is present in thecarbon fiber weave) and “baked” in an oven in order to cure or hardenthe material. In certain embodiments, portions of the outer brace 200may include fiberglass and resin materials. As an example, the strutmembers 202 may be fiberglass as opposed to carbon fiber. The innerbrace 300, on the other hand, may be manufactured from a thermoplasticmaterial, which is a polymer that becomes pliable or moldable above aspecific temperature and returns to a solid state upon cooling. Whilethe inner and outer brace 300, 200 are described as being constructedfrom the above materials, the braces may be manufactured from othermaterials as well.

The following discussion will focus on the manufacturing processesinvolved in making the outer and inner brace.

To begin, reference can be made to FIGS. 4-5, which are flowcharts ofthe manufacturing process for the inner brace. First, the process ofmanufacturing a custom AFO involves casting a patient's leg, ankle, andfoot [Block 400]. The casting may be done by putting a stockinet or sockon the patient's leg, ankle, and foot. Next, moistened, pre-impregnatedfiberglass wrapping can be wrapped around the lower leg, ankle, andfoot. Once the fiberglass cast hardens (e.g., 10 minutes), the cast maybe cut along a superior side of the foot and along an anterior side ofthe leg such that the portion of the cast that contacts the inferiorside of the foot and the posterior side of the leg remains intact andundamaged by the cutting. As seen in FIG. 6, the cast 312 is thenremoved from the patient's leg [Block 410]; the empty cast 312represents a “negative mold” of the patient's leg, ankle, and foot.Next, the cast 312 is sealed at the toe end of the cast and a plaster(e.g., Gypsum plaster) that has been mixed with water is poured into thecast [Block 420]. As seen in FIG. 7, once the plaster dries, the cast312 can be removed from the hardened plaster 314, which now represents a“positive mold” of the patient's leg, ankle, and foot [Block 430].

The plaster mold 314 is then modified by adding material (e.g., plaster)to certain areas of the plaster mold 314 to create a modified plastermold [Block 440] 316. For example, material 320 can be added to certainsurfaces 318 that correspond to boney surfaces of the foot and anklesuch as the ankle bones. The addition of material 320 to the plastermold 314 means that any molds that are formed on or over the modifiedplaster mold 316 will provide more room for the patient's boney surfacesin the areas where the plaster was added to the plaster mold 314. Inaddition to adding material 320 to the surfaces 318 on the mold 314 thatcorresponds to the boney portions of the patient's leg, ankle, and foot,and as seen in FIG. 8, material 320 can be added to the plaster mold 314in the area of the lip of the inner brace such that when a mold ismolded to the modified plaster mold 316, the inner brace 300 willinclude the lip.

The next step in the manufacturing process, as seen in FIG. 9, involvesmolding an inner brace shell 322. In this step, a thermoplastic 324 thathas been sufficiently heated so that it is pliable is wrapped around themodified plaster mold 316 [Block 450]. In particular, the thermoplastic324 can be wrapped around the modified plaster mold 316 from a singlesheet of thermoplastic material and can be wrapped from a posterior sideof the leg and an inferior side of the foot such that the thermoplasticmeets or joins on a superior side of the foot and an anterior side ofthe leg. Once the thermoplastic 324 hardens around the modified plastermold 316, the thermoplastic 324 may be removed from the modified plastercast 316 [Block 460]. For example, the thermoplastic 324 may be cutalong the superior side of the foot and the anterior side of the legsuch that the sides of the brace 322 that correspond with the posteriorside of the leg and inferior side of the foot remains intact.

Once the inner brace shell 322 is removed from the modified plaster cast316, the inner brace shell 322 can be cut to shape according to theillustration in FIG. 2 [Block 470]. The inner brace shell 322 can be cutwith a knife or shears, among other methods.

At this point, the process may diverge based on the particularembodiment of the outer brace is produced. For manufacturing the firstembodiment of the outer brace 100, reference is made to FIGS. 4, 6-17and [Blocks 480-560]. For manufacturing the second embodiment of theouter brace 200, reference is made to FIGS. 5-9, 18-19 and [Blocks600-670].

The next step involves an additional modification of the modifiedplaster mold 316. The modified plaster mold 316 is modified again byadding additional material (e.g., plaster) to the posterior side of themodified plaster mold 316 to form a second modified plaster mold [Block480]. In particular, the portion of the modified plaster mold thatcorresponds to about ¾ inch above the apex of the calcaneus isflattened. And, the flattening may extend to the calf. The flatteninginvolves adding material medial-laterally M/L across the modifiedplaster mold 316, of FIG. 8 for example, so that a nearly flat surfaceextends up to the calf from the apex of the calcaneus. As will bediscussed in further detail below, the flattening of this areafacilitates forming a flat strut member that extends from the lowersupport member to the calf-cuff member. Forming a flat strut member, asopposed to a patient specific contouring strut member, may ensureuniform mechanical characteristics of the strut member. Otherwise, astrut member that is contoured to the patient's anatomy could exhibitstress concentrations that affect performance of the AFO. Additionally,such a strut member could affect the rehabilitation of the patient byaltering the flexion point of the AFO.

Using the second modified plaster mold, a “dummy mold” 326 is formed bymolding a thermoplastic 324 over the second modified mold and, then,removing the mold 326 after it hardens [Block 490]. As illustrated inFIG. 10, the posterior side of the dummy mold is flat 328 from justabove the heal area to the calf area. The procedure is similar to asdescribed with respect to molding the inner brace [Block 450], exceptthat the dummy mold 326 is formed over the second modified plaster mold.Once the thermoplastic cools and hardens, the dummy mold 326 can beremoved from the second modified plaster mold in the manner describedwith respect to the inner brace 300 removal [Block 460]. The dummy mold326 provides a shell for “laying-up” or wrapping of layers of materialthat will ultimately become the outer brace 100. And, since theposterior side of the dummy mold 326 is flattened, the layers ofmaterial that are positioned on this area of the mold 326 will also beflat.

The next step involves layering sheets or layers of carbon fiber and/orfiberglass 330 on the dummy mold 326 in the areas that will ultimatelyform the outer brace 100 once the carbon fiber and/or fiberglass 330hardens [Block 500]. Thus, when the carbon fiber and/or fiberglass 330hardens, it will have an inner shape that corresponds to the outer shapeof the dummy mold 326. And, since the dummy mold 326 includes aflattened surface 328 on a posterior side of the lower leg area of thedummy mold 326, when the carbon fiber and/or fiberglass 330 is layeredon this area to form the strut member 116, the carbon fiber and/orfiberglass 330 will lay flat, which increases the strength of the strutmember 116. Additionally, layering the carbon fiber or fiberglass 330 insuch an orientation provides consistency that would not be achieved ifthe carbon fiber and/or fiberglass 330 was laid on a mold 326 that wascontoured to the specifics of the patient's anatomy. As statedpreviously, having a flat strut member 116 reduces the possibility ofstress concentrations, which could lead to pre-mature failure of theAFO. Thus, layering the carbon fiber or fiberglass 330 in a flatorientation leads to consistent manufacturing with less chance offailure.

An example procedure for layering carbon fiber to form the secondembodiment of the outer brace 200 is as follows. As seen in FIGS. 11-13,a first layer of bi-directional, pre-impregnated carbon fiber 330 can bemolded or wrapped around portions of the dummy mold that will ultimatelybe covered by the outer brace 200. Since the pre-impregnated carbonfiber 330 is often sticky due to the resin, the layers 330 tend to wrapeasily around the dummy mold 326 and tend to stick well to successivelayers of carbon fiber 330. As a note, other types of carbon fiber 330are useable within this process and are not limited to bi- oruni-directional, pre-impregnated carbon fiber. Next in the process, afirst layer of uni-directional, pre-impregnated carbon fiber 330 can bemolded or wrapped to the first layer of bi-directional carbon fiber 330.Again, a second layer of bi-directional, pre-impregnated carbon fiber330 can be molded or wrapped to the first layer of uni-directionalcarbon fiber 330. Thus, the three layers of carbon fiber form a sandwichwith two layers of bi-directional carbon fiber 330 on the outsides and asingle layer of uni-directional carbon fiber 330 in the middle. Carbonfiber can be layered on portions of the foot, ankle, and heel, as wellas layered in a similar manner around the calf area to form thecalf-cuff member. While the layers of carbon fiber are described asbeing a sandwich construction of two layers of bi-directional carbonfiber with a single layer of uni-directional carbon fiber, othercombinations are possible. For example, another combination of layersmay include two outer layers of bi-directional carbon fiber 330 with twoinner layers of uni-directional carbon fiber 330. This method oflayering up carbon fiber may be equally applicable to construction ofthe first embodiment of the outer brace 100, described previously.

For the strut member 116 of the first embodiment 100, a strip ofuni-directional, pre-impregnated carbon fiber 330 that is sandwichedbetween two layers of bi-directional, pre-impregnated carbon fiber 330can be positioned between the carbon fiber on the heal to the carbonfiber on the calf-cuff member 118. The strip can be about ⅝ inch wide toabout 1 inch wide depending on the strength and/or flexibilityrequirements of the strut member 116, which may be affected by the sizeand activity level of the patient. Alternatively, the strip can be otherwidths as necessitated by the requirements of the AFO. In certainembodiments, the coupling of the strut member 116 to the calf-cuff 118and/or the heal-end portion of the lower support member 102 can beaccomplished by positioning the strut member 116 between layers ofcarbon fiber on the respective calf-cuff member 118 and/or heal-endportion of the lower support member 102. For example, the heal-endportion of the lower support member 102 may include two inner layers ofuni-directional, pre-impregnated carbon fiber sandwiched between twoouter layers of bi-directional, pre-impregnated carbon fiber and thestrut member may be positioned between the two inner layers ofuni-directional carbon fiber.

As seen in FIG. 14, once the strut member 116 (obscured by thethermoplastic 332 in FIG. 14) is coupled to both the calf-cuff member118 and the heel-end portion of the lower support member 102, a thinlayer of thermoplastic 332 is positioned over the strut member 116[Block 510]. The layer of thermoplastic may be about 1/32 inch thick andmay be slightly wider than the strut member 116. The thin layer ofthermoplastic 332 will mold with the strut member 116 and will provideadditional stability to the strut member 116.

Next, a layer of plastic wrap (not shown), or similar material, iswrapped over the layers of carbon fiber 330 and the thin layer ofthermoplastic 332 [Block 520]. The plastic wrap ensures that the outersurface of the carbon fiber 330, once baked, will have a smooth coating.In addition to the plastic wrap, the entire assembly including the dummymold 326, carbon fiber 330, and the thin layer of thermoplastic 332 maybe sealed in a vacuum sealed bag (not shown) [Block 530]. The next stepis to put the dummy mold 326, carbon fiber 330, thin layer ofthermoplastic 332, plastic wrap, and vacuum sealed bag in an oven tobake [Block 540]. Oven temperature of about 250 degrees Fahrenheitshould be sufficient to bake both the carbon fiber 330 and the thinlayer of thermoplastic 332.

Once the baking process is complete, the carbon fiber 330 and thin layerof thermoplastic 332 can be removed from the dummy mold 326 and plasticwrap [Block 550]. At this point and as seen in FIGS. 15-17, the strutmember 116 or, more particularly, the edges of the thin thermoplastic332 can be trimmed and the carbon fiber 330 on the calf-cuff member 118and the lower support member 102 can be trimmed to the shape identifiedin FIG. 2A-2D [Block 560].

Now that a description of manufacturing the first embodiment of theouter brace 100 is complete, reference will now be made to FIGS. 18-19and [Blocks 600-670] in discussing the steps of manufacturing the secondembodiment of the outer brace 200.

Referring to FIGS. 5 and 9, after the inner brace shell 322 ismanufactured [Blocks 450-460], these steps are repeated a second time toform a second inner brace shell [Block 600]. It is noted that themodified plaster mold 316 is not subsequently modified in thisembodiment of the outer brace 200 to include the flat posterior section.Once the second inner brace shell is removed from the modified plastermold 316, the second inner brace shell is not cut to shape according toFIG. 2. Rather, the second inner brace shell is used to layer-up sheetsor layers of carbon fiber 330 to form the second embodiment of the outerbrace 200. In this step, layers of carbon fiber 330 are first laid up onthe foot plate 208, sidewall areas 212, and calf-cuff 224 of the secondinner brace shell to form the lower support member 204 and the calf-cuffmember 224 [Block 610]. It is noted that the heal-end portion of thesecond inner brace shell is not wrapped in carbon fiber 330 (i.e., tomake room for the large calcaneus opening 220). As seen in FIG. 1, theheal-end portion 206 of the outer brace 200 remains open. Alternatively,the heal-end portion 206 of the second inner brace shell may be wrappedwith carbon fiber 330 and subsequently cut-down after the outer brace200 is baked in the oven.

To couple the calf-cuff member 224 and the lower support member 204 apair of strut members 202 is formed by using fiberglass and resin 334.While various types of fiberglass 334 may be used, fiberglass “G-braid”may be used in this application along with an epoxy resin. Inparticular, epoxy resin is added to strips of fiberglass 334 and thestrips of fiberglass 334 are laid on the second inner brace shell withthe respective ends of the strips protruding into each of the calf-cuffmember 224 and the lower support member 204 [Block 620]. Each of thestrips of fiberglass 334 extends into the lower support member 204 at anapproximate 45 degree angle, as shown by the dotted lines in FIG. 18. Asthe strips of fiberglass 334 extend upwards towards the calf-cuff member224, the strips overlap at about a mid-point between the calf-cuffmember and the lower support member 204. And, as seen by the dottedlines in FIG. 19, the combined strips of fiberglass 334 extend into thecalf-cuff member 224 about ½ to about ¾ of the way up the calf-cuffmember 224. As discussed with respect to the first embodiment of theouter brace 100, the strut members 202 may extend into the respectivecalf-cuff member 224 and lower support member 204 between layers of thecarbon fiber 330.

Once the carbon fiber 330 and the fiberglass 334 are wrapped around thesecond inner brace shell, a thin layer of plastic wrap (not shown), orsimilar material, is wrapped over the assembly [Block 630]. Next, theentire assembly including the second inner brace shell, carbon fiber330, fiberglass 334 and the plastic wrap may be sealed in a vacuumsealed bag [Block 640]. The next step is to put the entire assembly,including the vacuum sealed bag, in an oven to bake [Block 650]. Afterbaking in the oven for a sufficient time to harden the material, thecarbon fiber and fiberglass can be separated from the second inner braceshell and plastic wrap [Block 660]. Finally, portions of the strutmembers 202, the calf-cuff member 224, and the lower support member 204may be trimmed to the shape identified in FIG. 1 [Block 670].

Referring to FIG. 20-21, a third embodiment of an outer brace 400 for anAFO is shown. As seen in the figures, the outer brace 400 includes alower support member 402 that is similar to the previous embodiments ofthe outer brace 100, 200. That is, the lower support member 402 includesa foot plate 404 having opposing sidewall members 406 with a mid-footraised edge 412 extending proximally from a mid-region of the foot plate404. The outer brace 400 in FIGS. 20-21 is different from previousembodiments in that it includes a helical or spiral shaped strut member408 that extends superiorly or upward from one of the side wall member406 (i.e., the strut member 408 may extend from a medial or lateral sideof the foot plate 404). On one of the medial or lateral sides of thefoot plate 404, the mid-foot raised edge 412 extends proximally andtransitions into an edge 420 of the strut member 408. As the strutmember 408 extends upward, it spirals or wraps around a posterior orheal side of the brace 400 and couples to or transitions to a shin-cuffmember 410 that wraps around and supports an anterior side of apatient's front part of the leg or shin area. As an example, if thestrut member 408 extends upward from a medial side of the foot plate404, the strut member 408 will wrap around the heal side and couple ortransition to the shin-cuff member 410 on the lateral side of thepatient. The side wall member 406 that does not couple to or transitionto the strut member 408 includes a posterior raised edge 414 that wrapsaround the heal portion 416 of the lower support member 402 andtransitions into another edge 418 of the strut member 408. The strutmember 408 defines a gap, opening, or open area between the foot plate404 and the edge 418 of the strut member 408 directly upward or superiorfrom the foot plate 404 such that the patient's heal area issubstantially unobstructed by a portion of the brace 400 on the healside.

As with other embodiments, the shin-cuff member 410 may include afastener mechanism such as a Velcro strap that couples the shin-cuffmember 410 to the patient's leg. The outer brace 400 shown in FIGS. 20and 21 may be used on a patient's left or right leg, and in certainembodiments, the outer brace 400 may be mirrored for the patient'sopposite leg such that the strut member 408 extends from opposite sidewall members 406 of each respective foot's brace.

The outer brace 400 may be constructed in similar ways as the previouslydescribed embodiments of the outer brace 100, 200. That is, the brace400 may be constructed of carbon fiber and/or fiberglass using thepreviously described methods. Additionally, the strut member 408 may beof a substantially constant or uniform width between the edges 418, 420during the extension from the foot plate 404 to the shin-cuff member 410of about 1 inch, 1.5 inches, 2 inches, 2.5 inches, or 3 inches, amongother possible widths. In certain embodiments, the width may be anypossible width between about 0.5 inch to about 4 inches.

Referring to FIG. 22-26, a fourth embodiment of an outer brace 500 foran AFO is shown. As seen in the figures, the outer brace 500 includes alower support member 502 that includes a foot plate 504 having opposingsidewall members 506 with a mid-foot raised edge 512 extendingproximally from a mid-portion of the foot plate 504. The outer brace 500in FIGS. 22-26 is different from previous embodiments in that itincludes a single, curved strut member 508 that extends superiorly orupward from the side wall member 506 on the medial side 526 of the footplate 504. That is, there is no strut member extending from a lateralside 528 of the foot plate. It is noted that while the strut 508 isdescribed as coupling or transitioning from a medial side 526 of thefoot plate 504, in certain instances, the strut member 508 mayalternatively couple or transition from a lateral side 528 of the footplate 504 without departing from the teachings of the presentdisclosure.

As seen in FIGS. 22-26, the curved strut member 508 includes an inferioror lower section 522 that is curved and that couples with the foot plate504 at the medial side 526. The curved strut member 508 also includes asuperior or upper section 524 that is generally straight and thatcouples with a calf-cuff member 510 on a posterior side. The mid-footraised edge 512 on the medial side 526 extends proximally andtransitions into an edge 520 of the strut member 508 at the lowersection 522. As the strut member 508 extends upward from the foot plate504, it curves around a posterior or heal side of the brace 500. Thecurved lower section 522 transitions to the generally straight uppersection 524 above a heal region to be occupied by the heal portion of aninner brace 530, shown in broken line in FIG. 25. Above the heal region,the strut member 508 extends upward or superiorly to the calf-cuffmember 510 on a posterior side.

Stated differently, the curved strut member 508 couples with the footplate 504 at an arch region 538 of the plate 504, as seen in FIG. 26,while leaving open the heal side of the foot plate 504 so as to allowthe inner brace 530, as seen in FIG. 25, to occupy the heal side of thefoot plate 504 without being encumbered by the strut member 508. In thisway, the strut member 508 may be positioned over the patient's medialmalleolus while curving around and superior to the calcaneus and, inparticular, the point where the calcaneus meets the calcaneal tendon.From the point superior to the calcaneus, the strut member 508 extendslinearly in a superior direction to the calf-cuff member 510.

The calf-cuff member 510 wraps around the posterior, medial, and lateralsides of the patient's leg or calf area. The calf-cuff member 510 isopen on an anterior side, allowing the patient to position his or herleg therethrough.

As illustrated in FIGS. 22-26, the side wall member 506 on the lateralside 528 does not couple to or transition to the strut member 508.Instead, a posterior raised edge 514 of the side wall member 506 on thelateral side 528 wraps around a heal portion 516 of the lower supportmember 502 and transitions into a lateral edge 518 of the strut member508. The lower section 522 of the strut member 508 defines a gap,opening, or open area between the foot plate 504 and the edge 518 of thestrut member 508 directly upward or superior from the foot plate 504such that the patient's heal area is substantially unobstructed by aportion of the brace 500 on the heal side.

As seen in FIG. 25, which is a side view of the outer brace 500 from thelateral side 528 showing an inner brace 530 in broken line, the gap oropen area between the foot plate 504 and the lateral edge 518 of thestrut member allows for the inner brace 530 to be positioned within theouter brace 500 and to be seated such that a most posterior point 532 oneither of the combined inner/outer brace 530, 500 is on the inner brace530. Since the patient wears the AFO including both the inner and outerbraces 530, 500 inside a shoe, the cumulative size of the inner andouter braces of the AFO affects the size of shoe the patient can wear.Thus, having the most posterior point 532 located on the inner brace 530means the patient only has to compensate additional shoe sizes for theinner brace 530 in a lengthwise direction (heal-to-toe). That is, if themost posterior point 532 were to be on the outer brace 500, the patientwould likely have to compensate shoe sizes for the thicknesses of boththe inner and outer braces 530, 500 in the lengthwise direction. In thisway, keeping the heal area open allows for the inner brace 530 to bepositioned more posteriorly or towards the heal area such that it sitsmore posterior than the outer brace 500.

As with other embodiments, the calf-cuff member 510 may include afastener mechanism such as a Velcro strap that couples the calf-cuffmember 510 to the patient's leg. The outer brace 500 shown in FIGS.22-26 may be used on a patient's right leg and, in certain instances,the outer brace 500 for the patient's left leg may be mirrored where themedial and lateral sides 526, 528 are opposite to that shown in FIGS.22-26.

Regarding manufacturing, the outer brace 500 may be constructed insimilar ways as the previously described embodiments of the outer brace100, 200, 400. That is, the brace 500 may be constructed of carbon fiberand/or fiberglass using the previously described methods. Additionally,the strut member 508 may be of a substantially constant or uniform widthbetween the edges 518, 520 during the extension from the foot plate 504to the calf-cuff member 510 of about 1 inch, 1.5 inches, 2 inches, 2.5inches, or 3 inches, among other possible widths. In certainembodiments, the width may be any possible width between about 0.5 inchto about 4 inches.

In certain instances, as seen in FIGS. 23-24 and 26, the strut 508 mayinclude an inner strut member 534 (shown in broken line) sandwichedwithin an outer strut member 536. The inner and outer strut members 534,536 may, for example, be formed by layering up a first set of carbonfiber layers, positioning a central carbon fiber band on the first setof carbon fiber layers, and then layering up a second set of carbonfiber layers (similar to the first set of carbon fiber layers) tosandwich the central carbon fiber band. In this example, the centralcarbon fiber band is the inner strut member 534 and the first and secondcarbon layers are the outer strut member 536. In certain instances, theinner strut member 534 may be about ⅝ inch wide. In certain embodiments,the inner strut member 534 may be any width between about ¼ inch wide toabout 1 inch wide.

As seen in FIG. 26, which is a side view of the outer brace 500 from themedial side 526, the inner strut member 534 may be fanned out,feathered, or widened at an arch region 538 near the foot plate 504.That is, the width of the inner strut member 534 at the arch region 538may be wider than the inner strut member 534 at other portions of thestrut member 508. The inner strut member 534 being wide at the archregion 538 provides strength and rigidity to the outer brace 500 sinceflexing of the outer brace 500 occurs throughout the arch region 538 andlower section 522 of the strut member 508.

Patients requiring an AFO often over-pronate, which means their feetroll inward and onto the arches of the foot. Providing strength andrigidity on the medial side 526 at the arch region 536 concentrates thematerial of the brace 500 at the area where the patient is most likelyto pressure or stress the brace 500. And since the brace 500 is neededto provide arch support for the inner brace 530, shown in broken line inFIG. 25, the arch region 538 is ideally situated for the positioning ofa wider portion of the inner strut member 534.

The outer brace 500 can be manufactured as described with reference tothe previous embodiments of the outer brace 100, 200, 400. In certaininstances, the step of modifying the modified plaster mold by addingadditional material (e.g., plaster) to the posterior side of themodified plaster mold to form a second modified plaster mold at [Block480] of FIG. 4 may also include adding plaster to the along the medialside 526 at the arch region 536. The additional material is added andflattened, as opposed to allowing a patient specific contour to remain.The flattening of this area facilitates forming a strut member 508 witha flat inner surface that extends from the foot plate 504 to thecalf-cuff member 510. Forming a flat strut member 508, as opposed to apatient specific contouring strut member, may ensure uniform mechanicalcharacteristics of the strut member 508. Otherwise, a strut member 508that is contoured to the patient's anatomy could exhibit stressconcentrations that affect performance of the AFO. After forming thesecond modified plaster mold, the manufacturing process continues asdescribed previously.

An exemplary construction of the outer brace 500, at Block [500] of FIG.4, may include the following layers of material from inside to outside:resin; fabric (e.g., suede-type fabric); thermoplastic; multiple layersof carbon fiber (e.g., alternate layers of bi-directional anduni-directional carbon fiber); polyethylene; fabric; and, resin. Otherarrangements of layers are possible and contemplated herein.

Although various representative embodiments of this invention have beendescribed above with a certain degree of particularity, those skilled inthe art could make numerous alterations to the disclosed embodimentswithout departing from the spirit or scope of the inventive subjectmatter set forth in the specification. All directional references (e.g.,top, bottom, front, back) are only used for identification purposes toaid the reader's understanding of the embodiments of the presentinvention, and do not create limitations, particularly as to theposition, orientation, or use of the invention unless specifically setforth in the claims. Joinder references (e.g., attached, coupled,connected, and the like) are to be construed broadly and may includeintermediate members between a connection of elements and relativemovement between elements. As such, joinder references do notnecessarily infer that two elements are directly connected and in fixedrelation to each other.

In methodologies directly or indirectly set forth herein, various stepsand operations are described in one possible order of operation, butthose skilled in the art will recognize that steps and operations may berearranged, replaced, or eliminated without necessarily departing fromthe spirit and scope of the present invention. It is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative only and not limiting.Changes in detail or structure may be made without departing from thespirit of the invention as defined in the appended claims.

What is claimed is:
 1. An ankle-foot orthosis for a lower leg includinga calf, ankle, and foot of a patient, the ankle-foot orthosiscomprising: a foot plate comprising a toe side, a heal side opposite thetoe side, a medial side including an arch region, and a lateral sideopposite the medial side; a calf-cuff member configured to abut the calfof the patient; and a support member extending between the foot plateand the calf-cuff member, the support member consisting of a strutmember including a curved lower section and a straight upper section,the curved lower section extending from the arch region of the medialside of the foot plate to a posterior position above the heal side ofthe foot plate, the curved lower section transitioning to the straightupper section at the posterior position, the straight upper sectionextending superiorly to the calf-cuff member.
 2. The ankle-foot orthosisof claim 1, wherein the heal side defines a gap between the strut memberand the foot plate.
 3. The ankle-foot orthosis of claim 1, wherein theheal side of the foot plate is unconnected to the strut member.
 4. Theankle-foot orthosis of claim 1, wherein the strut member is widest atthe arch region.
 5. The ankle-foot orthosis of claim 1, wherein the footplate is custom contoured to the foot of the patient.
 6. The ankle-footorthosis of claim 1, wherein the calf-cuff is custom contoured to thecalf of the patient.
 7. The ankle-foot orthosis of claim 1, wherein atleast one of the foot plate or the calf-cuff member is custom contouredto the calf of the patient, and wherein an inner surface of the strutmember is not custom contoured to the patient.
 8. The ankle-footorthosis of claim 1, wherein a heal portion of an inner brace positionedwithin the ankle-foot orthosis extends further posteriorly than anyportion of the ankle-foot orthosis.
 9. The ankle-foot orthosis of claim1, wherein the strut member is constructed of carbon fiber.
 10. Theankle-foot orthosis of claim 9, wherein the strut member is constructedof layers of bi-directional and uni-directional carbon fiber.
 11. Amethod of manufacturing a custom ankle-foot orthosis for a patient'slower leg and foot, the method comprising: forming an inner brace frommolding a first material over a first portion of a positive mold of thepatient's lower leg and foot; modifying the positive mold to form amodified positive mold; and forming an outer brace by molding at leastone second material over a second portion of the modified positive mold.12. The method of claim 11, wherein the first material is athermoplastic material.
 13. The method of claim 11, wherein the at leastone second material comprises carbon fiber.
 14. The method of claim 13,wherein the at least one second material further comprises athermoplastic material.
 15. The method of claim 11, wherein the positivemold comprises a cast of the patient's lower leg and foot.
 16. Themethod of claim 11, wherein modifying the positive mold to form themodified positive mold comprises removing custom contouring aspects ofthe positive mold.
 17. The method of claim 11, wherein modifying thepositive mold to form the modified positive mold comprises forming aflattened portion of the positive mold.
 18. The method of claim 17,wherein the flattened portion of the positive mold comprises a bandextending from a posterior region to a medial arch region.
 19. Themethod of claim 17, wherein the outer brace comprises a foot plate, acalf-cuff member, and a strut member coupled between the foot plate andthe calf-cuff member, the flattened portion of the positive moldcomprise an area to which the strut member is molded.
 20. The method ofclaim 19, wherein the outer brace includes only one strut membercomprising the strut member.